FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P100045
·
Supplement: S065
·
Decision Apr 28, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- System, Hemodynamic, Implantable
- Trade Name
- CardioMEMS HF System
- PMA Number
- P100045
- Supplement Number
- S065
- Device Class
- FDA Class 3
- Product Code
- MOM
- Generic Name
- System, hemodynamic, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 28, 2023
- Date Received
- March 31, 2023
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling changes being made to the users manual or system guides with updated electromagnetic compatibility (EMC) information.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOM | System, Hemodynamic, Implantable | FDA class 3 | Unknown |